Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2025-12-25 @ 11:15 PM
Study NCT ID:
NCT01170793
Status:
COMPLETED
Last Update Posted:
2012-12-27
First Post:
2010-07-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Medicine Abuse Headache
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-26', 'studyFirstSubmitDate': '2010-07-26', 'studyFirstSubmitQcDate': '2010-07-26', 'lastUpdatePostDateStruct': {'date': '2012-12-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "To evaluate the efficacy of educative telephone coaching administered by the center's nurses prior to the medical on-site visit.", 'timeFrame': 'within 6 months'}], 'secondaryOutcomes': [{'measure': 'To evaluate the efficacy of educative telephone coaching (ETC) on the frequency of headaches and on the number of days with crisis treatment intake.', 'timeFrame': 'within 6 months'}, {'measure': 'To evaluate the efficacy of ETC on the patients quality of life and their handicap (emotional, professional and familial data)', 'timeFrame': 'within 6 months'}, {'measure': "To evaluate the patient's satisfaction toward ETC", 'timeFrame': 'within 6 months'}, {'measure': "To evaluate the patient's knowledge concerning migraine, medication overuse headache and their treatment after ETC", 'timeFrame': 'within 6 months'}, {'measure': 'To estimate the cost/benefits ratio of ETC and its impact on medical costs ahead of the medical appointment.', 'timeFrame': 'within 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['education, quality of life'], 'conditions': ['Migraine']}, 'descriptionModule': {'briefSummary': 'In patients with MOH, we will evaluate the impact of educative telephone coaching on the number of days with headache over the month preceding the appointment. The educative coaching will be administered by a nurse, during a single phone call and prior to the medical visit', 'detailedDescription': 'In tertiary centers, it is not unusual for patients to wait for 6 months for a medical appointment. This clinical trial is monocentric, open, randomised. In the first arm, the patients will receive educative telephone coaching at Month 2 by the nurses, over the phone. In the second arm, the patients will not receive any educative telephone coaching before the appointment with the neurologist.\n\nAll patients will complete "Quality of life" questionnaires at Month 1 and Months 6, complete a migraine agenda during the length of the study and have a medical appointment around Month 6.\n\nThe primary outcome will be the efficacy of such educative telephone coaching, administered before the medical appointment in the Chronic Pain Center, in Bordeaux. It will be measured by the number of days with headache over the month preceding the appointment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults, male or female, \\> 18 years old\n* Patients with a presumptive medication overuse headache diagnostic (\\>15 days/month with migraines, \\> 10 days/month intake of crisis treatment)\n* Persons calling the Chronic Pain Center in Bordeaux and asking for a medical appointment\n* Informed and written consent, dated and signed by the patient and the investigator prior to any study related procedure\n\nExclusion Criteria:\n\n* Patients with a differential diagnostic (other primitive headaches and secondary headaches)\n* Persons non affiliated to a social security system\n* Persons who refuse to participate in the study.'}, 'identificationModule': {'nctId': 'NCT01170793', 'acronym': 'CAM-ET', 'briefTitle': 'Medicine Abuse Headache', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': 'Medication Overuse Headaches: the Impact of Educative Telephone Coaching Administered by Nurses Prior to the Medical Appointment in a Tertiary Consultation Center: a Comparative Randomized Trial', 'orgStudyIdInfo': {'id': 'CHUBX 2009/16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': '2', 'description': 'no educative telephone coaching (ETC)'}, {'type': 'EXPERIMENTAL', 'label': '1', 'description': 'with educative telephone coaching (ETC)', 'interventionNames': ['Behavioral: educative telephone coaching (ETC)']}], 'interventions': [{'name': 'educative telephone coaching (ETC)', 'type': 'BEHAVIORAL', 'description': 'a 30 to 45 minutes phone call, by appointment, by the nurse', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Centre Douleur Chronique - Groupe Hospitalier Pellegrin - Bât USN Tastet Girard', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}], 'overallOfficials': [{'name': 'Geneviève Chene, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital, Bordeaux'}, {'name': 'Virginie Dousset, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Bordeaux'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fondation Apicil', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}